Drug Brand Name Extensions

On 6 July 2026, the Central Drugs Standard Control Organisation (CDSCO) invited feedback and suggestions from stakeholders on the use of brand name extensions by pharmaceutical firms, signalling the regulator’s intent to examine concerns surrounding the practice and its potential implications for patient safety and the rational use of medicines.

Background:

The Directorate General of Health Services (DGHS) received representations regarding the marketing of different drug formulations under the same established brand name through the use of various brand name extensions.

The matter was subsequently deliberated by the 67th Drugs Consultative Committee (DCC) at its meeting held on 17 November 2025. During the deliberations, the DCC was informed of a representation alleging that a pharmaceutical company was marketing multiple drug formulations under a common brand name while using different extensions. Concerns were raised that the use of similar brand names for medicines containing different active pharmaceutical ingredients could mislead consumers and healthcare professionals, potentially creating confusion regarding their therapeutic indications and intended use.

Key takeaways:

  1. The DCC recommended undertaking a broader stakeholder consultation to examine the issue comprehensively.

  2. The Committee highlighted the need to assess the implications of brand name extensions on prescribing practices, patient understanding, patient safety, and the potential for therapeutic confusion.

  3. As part of the consultation process, CDSCO has uploaded the DCC’s recommendations on its website and invited comments from all stakeholders, including pharmaceutical companies, healthcare professionals, industry associations, and consumer groups.

  4. The stakeholders are allowed to submit their comments and suggestions on or before 17 July 2026 via email at enforcecell.div@cdsco.nic.in.

  5. The consultation is expected to help CDSCO determine whether additional regulatory measures are required to address concerns arising from the use of brand name extensions for medicines containing different active pharmaceutical ingredients and intended therapeutic uses.

Also Read: Cosmetics Are Not Medicines: CDSCO Prohibits Injectable Use

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